Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900

K-Number: K100585 · 2011-01-20

ApplicantGaymar Industries, Inc.
Decision Date2011-01-20
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 2011-01-20 under 510(k) number K100585. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900?

MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K100585.

When did MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 receive FDA 510(k) clearance?

MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 received FDA 510(k) clearance on 2011-01-20, under 510(k) number K100585.

Who is the listed applicant for MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900?

The FDA 510(k) record lists Gaymar Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900?

The FDA product code for MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 is DWJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gaymar Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPK962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMK963067SOF. PRESS EPC 51 SYSTEMK961854SPR PLUS II OVERLAY SYSTEM (CL250/CL212K942881TC 3000K930345TC2000 POWER UNIT AND ACCESSORIES

View all 27 devices →

Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑